NCT01053078

Brief Summary

Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death. Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia. The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 12, 2014

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

4.7 years

First QC Date

January 19, 2010

Results QC Date

September 4, 2014

Last Update Submit

January 27, 2020

Conditions

Type 1 DiabetesHypoglycemia Unawareness

Keywords

Type 1 diabetesHypoglycemia unawarenesslow blood sugar

Outcome Measures

Primary Outcomes (1)

  • Cerebral Blood Flow

    1 month

Secondary Outcomes (1)

  • Hypoglycemia Symptom Score

    1 month

Study Arms (2)

Naltrexone

EXPERIMENTAL
Drug: Naltrexone

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

NaltrexoneDRUG

1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days

Also known as: ReVia
Naltrexone
PlaceboOTHER

1 month treatment; placebo tablet once daily for 28 days

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Type 1 diabetes
  • Hypoglycemia unawareness
  • Capable of providing informed consent

You may not qualify if:

  • Concomitant regular use of acetaminophen, aspirin or ibuprofen
  • History of drug or alcohol abuse
  • Psychiatric illness
  • Elevations in ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), creatinine or history of hepatitis, liver failure, or renal failure/insufficiency
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

  • Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.

    PMID: 34282646DERIVED

  • Moheet A, Mangia S, Kumar A, Tesfaye N, Eberly LE, Bai Y, Kubisiak K, Seaquist ER. Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes: A randomized clinical trial. J Diabetes Complications. 2015 Nov-Dec;29(8):1277-82. doi: 10.1016/j.jdiacomp.2015.08.004. Epub 2015 Aug 12.

    PMID: 26345338DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Elizabeth Seaquist
Organization
University of Minnesota
seaqu001@umn.edu
612 624 9176

Study Officials

  • Elizabeth R Seaquist, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 5, 2020

Results First Posted

September 12, 2014

Record last verified: 2020-01

Locations

US(1)